BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    IMAGEnet 6 Ophthalmic Data System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100783·FLIERINGA FIXATION RING 17MM

    NOBELACTIVE INTERNAL NP 3.5X11.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 13, 2020

    NOBELACTIVE INTERNAL RP 4.3X10MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA INC·Product code DZE·September 8, 2020

    NOBELACTIVE INTERNAL NP 3.5X11.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 13, 2020

    ODALYS PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOBELACTIVE INTERNAL CONNECTION IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·June 14, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 21, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·August 11, 2020

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012